Package Design Innovation

Transcription

1 Package Design Innovation Reveal ICM Sterile Packaging Solution March 2-4,

2 Acknowledgments Agenda ICM/Reveal Product Overview Previous Sterile Barrier System Design for Reveal Previous pre-implant mapping procedure for Reveal Design Challenge New Sterile Barrier System Design Testing Vector Check TM

3 Acknowledgments CRDM Package Engineering Judy Salzer Glenn Biddick Systems Engineering Paul Krause Bill Plombon Val Eisele Human Factors Engineering Bill Wenger Oliver-Tolas John Kortman

4 What is an ICM? Insertable Cardiac Monitor (ICM) Programmed to continuously monitor the heart s activity in the form of an electrocardiogram (ECG) The insertable cardiac monitor is the standard of care determining the causes of infrequent, unexplained fainting (syncope.)

5 Benefits By looking at your heart rhythms before, during, and after a fainting spell, your doctor may be able to identify whether the cause of your unexplained fainting is heart-related. If a heart rhythm-related cause is found, your doctor may recommend therapy based on the exact cause. Other types of heart monitors are attached on the outside of your body for 2 to 60 days. The insertable cardiac monitor is designed for longterm use.

6 Risks All surgical procedures carry some risk. Because the ICM is implanted just beneath the skin, there is a slight risk of: Infection abrasion sensitivity to the cardiac monitor material

7 Reveal Insertable Cardiac The Reveal DX and Reveal XT Insertable Cardiac Monitors. About the size of a jump drive. Implanted under the skin in the upper chest area. Packaged with an external device called a patient activator. Monitor

8 Reveal Insertable Cardiac Monitor External Electrodes

9 Implant Location

10 Previous Sterile Barrier System Previous Reveal models were packaged in a double sterile barrier tray system, identical to the SBS for pacemakers and defibrillators.

11 Pre Implant Mapping Procedure designed to locate the preferred implant site. Preferred device position. Confirm reliable sensing

12 Pre Implant Mapping Pre implant mapping is crucial because even slight changes in implant site or device position can have a significant influence on signal quality and R-wave amplitude. Very important when the ICM is programmed in auto-activation mode.

13 Previous Pre Implant Mapping Procedure The pre-implant mapping tool consisted of a paper-board template and seven snap electrodes, plus the ECG feature on the 2090 programmer, to collect ECG waveforms associated with four potential implant orientations. Electrodes had to be placed roughly 4cm apart to match the subcutaneous spacing of the ICM electrodes.

14 Implant Zone

15 Issues with the pre implant mapping procedure Required increased procedure time for set up of external instrumentation. Required several additional accessories (snap electrodes, cables, and the programmer.) Use of an external ECG system does not always match 1:1 what the implanted device will see in the same location.

16 Example of signal mismatch

17 Reveal XT/DX Project Innovative opportunity to improve pre implant mapping. Systems engineers thought it would be cool to use the reveal device itself to perform the mapping. Since the Reveal device has external electrodes and can be activated using telemetry, mapping can be done with the device in the sterile package.

18 Package Design Challenge Create a sterile barrier system that allows the device to be electrically connected to the patient for pre-implant mapping without compromising the sterility of the device. The design went through several iterations during development before identifying the best materials and configuration.

19 Sterile Barrier System

20 The Conductive Lid Die cut Tyvek 1073B, dot coated with Oliver- Tolas hotmelt adhesive Flexible conductive vinyl circuit laminated to the inside facing surface of the lid Circuit runs through the seal and terminates at the end of the tail, outside of the sterile barrier

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22 Device Interface Inside the package

23 Zone Coat Additional hot melt adhesive is zone coated in the area where the circuit passes through the seal. After SBS sealing, the circuit material is completely surrounded by adhesive, ensuring a complete sterile barrier

24 Inner Tray Design holds the device in the proper orientation for electrode contact

25 The Tail Spacing of the electrodes is the same as the spacing of the Reveal electrodes. ~4cm Image of the device is printed on the tail as a reminder of device orientation. It is important to know which electrode is which.

26 Hydrogel electrode patches Promote electrical contact with the skin to take the surface ECG

27 Hydrogel electrode patches

28 Foam Dots

29 Final Package Assembly

30 Verification activities Many experiments taking readings off of engineers. Toxicological risk assessment/biocompatibility testing Sterilization validation Sealing validations Performance testing Shelf life stability

31 Pre Implant Mapping using Vector Check TM

32 Pre Implant Mapping using Vector Check TM

33 Implant Zone

34 Canine Example Vector Check ECG Implanted Reveal ECG

35 Use of Vector Check TM Implant procedures with the use of Vector Check TM results in higher signal quality Less false episodes due to undersensing Lower noise burden

36 Key Take Away As a packaging engineer Work closely with development engineers Understand the functionality of the device Partner with suppliers to maximize capabilities and innovation

37 Thank You